search
Back to results

iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain (iACT)

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iACTwithPain (ACT+compassion)
ACT-only intervention
Sponsored by
University of Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, contextual behavioral intervention, acceptance and commitment therapy, mindfulness, compassion-based therapy, online intervention

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 to 50;
  • a CP diagnosis at least for the last three months;
  • access to internet and willingness to do it regularly (at least once a week)
  • willingness to be randomized
  • provide informed consent.

Exclusion Criteria:

  • undergoing any other form of psychological intervention for CP;
  • severe psychiatric problem (e.g. severe depression; psychotic illness; bipolar disorder; borderline personality disorder), assessed using several questions (self-reported) based on the diagnostic criteria according to DSM-V;
  • pain due to malignancy, trauma, or surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    iACTwithPain

    ACT-only intervention

    Wait list (inactive control)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pain impact.
    The 6-item Pain Impact Questionnaire (PIQ-6 (52,53) ) will be used to assess participants' perceived pain severity (1 item rated on a 6-point scale) and impact on emotional well-being, leisure activities, and work functioning (5 items rated on a 5-point scale).

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2019
    Last Updated
    June 8, 2020
    Sponsor
    University of Coimbra
    Collaborators
    Fundação para a Ciência e a Tecnologia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04200183
    Brief Title
    iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain
    Acronym
    iACT
    Official Title
    iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    December 30, 2021 (Anticipated)
    Study Completion Date
    March 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Coimbra
    Collaborators
    Fundação para a Ciência e a Tecnologia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This project aims to test the effectiveness of an ICT-based delivery of an evidencebased psychological intervention for Chronic Pain (CP) - iACTwithPain. CP is a prevalent health problem worldwide, including in Portugal (around 30% of population) placing a significant economic burden on healthcare systems. Although CP is associated with psychological symptoms (i.e. depression and anxiety) and poor social functioning and quality of life, there is a lack of nationwide provision of evidence-based psychological services in healthcare units for CP. Information and Communication Technologies (ICTs) offer attractive tools through which self-management programmes can be delivered. The dissemination and commercialization of iACTwithPain will provide a much-needed pain self-management service and its ICT-based delivery form will increase the accessibility in large cohorts of the population with limited access to standard treatment.
    Detailed Description
    This project aims to develop and deliver an ICT self-management intervention for chronic pain (CP)-iACT. As persistent pain of different etiologies represents a medical, social and economic burden, optimized management of pain tools to support CP patients in adjusting to their condition and improving quality of life is timely and can lead to more costeffective healthcare systems by promoting the management of CP outside health institutions. While CP influences and is influenced by psychological factors, provision of care to CP patients in Portugal vastly disregards psychological interventions. In contrast, the usual treatment to CP in Portugal is primarily pharmacologic, which has limited effects. Psychological interventions are well suited for addressing the cognitive, emotional and behavioral factors that contribute to and result from pain-related distress. Acceptance and Commitment Therapy(ACT) is an evidence-based psychological approach for CP. ACT focuses on fostering acceptance of the unavoidable aspects of pain and directing efforts towards behavioral functioning, rather than the traditional focus on controlling pain, which disregards the patient's overall functioning and well-being. Also, studies suggest that self-compassion mediate the change in disability and psychopathological symptoms in ACT interventions for CP, although self-compassion is not a specific target in ACT. Thus, an explicit focus on self-compassion might increase the efficacy of ACT interventions, although this hypothesis has not been tested. Online interventions have several advantages: reducing therapist time and waiting lists, increased cost-effectiveness, patients working at their own pace, accessibility to large clinical samples and rural and remote clinical cohorts. However, evidence for the effectiveness of online-delivered ACT for CP is still scarce, with only three studies with several methodological limitations (i.e. small sample size and non-randomization). The innovative features of the current project are:1)the development of an ICT solution for self-management of pain, and improvement of overall well-being tailored to CP patients;2) the improvement of an ACT intervention by including psychological symptoms, and the increase in overall functioning and quality of life of CP patients; b)adding a new component(self-compassion) to the intervention will increase its effectiveness;c) its format will be a cost-effective solution for self-management of CP. The research strategy to achieve the project's goals follows a randomized controlled trial design with three arms: 1.iACTwithPain intervention (ACT + self-compassion); 2. ACT-only intervention; 3.Waiting List. iACTwithPain may also impact on other spheres of patients' lives such as work (e.g.,less absenteeism) and social (e.g.,less restrictions for leisure activities), which will contribute to more social inclusion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    chronic pain, contextual behavioral intervention, acceptance and commitment therapy, mindfulness, compassion-based therapy, online intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    246 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    iACTwithPain
    Arm Type
    Experimental
    Arm Title
    ACT-only intervention
    Arm Type
    Experimental
    Arm Title
    Wait list (inactive control)
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    iACTwithPain (ACT+compassion)
    Intervention Description
    This intervention will deliver a eHealth ACT and compassion-based therapy (iACTwithPain) designed for chronic pain
    Intervention Type
    Behavioral
    Intervention Name(s)
    ACT-only intervention
    Intervention Description
    This intervention will deliver the iACTwithPain intervention but without the delivery of explicit compassion.
    Primary Outcome Measure Information:
    Title
    Pain impact.
    Description
    The 6-item Pain Impact Questionnaire (PIQ-6 (52,53) ) will be used to assess participants' perceived pain severity (1 item rated on a 6-point scale) and impact on emotional well-being, leisure activities, and work functioning (5 items rated on a 5-point scale).
    Time Frame
    baseline, 8 weeks, 3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 18 to 50; a CP diagnosis at least for the last three months; access to internet and willingness to do it regularly (at least once a week) willingness to be randomized provide informed consent. Exclusion Criteria: undergoing any other form of psychological intervention for CP; severe psychiatric problem (e.g. severe depression; psychotic illness; bipolar disorder; borderline personality disorder), assessed using several questions (self-reported) based on the diagnostic criteria according to DSM-V; pain due to malignancy, trauma, or surgery.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paula Castilho, PhD
    Phone
    239 851 450
    Ext
    375
    Email
    paulacastilhofreitas@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    33767648
    Citation
    Carvalho SA, Trindade IA, Duarte J, Menezes P, Patrao B, Nogueira MR, Guiomar R, Lapa T, Pinto-Gouveia J, Castilho P. Efficacy of an ACT and Compassion-Based eHealth Program for Self-Management of Chronic Pain (iACTwithPain): Study Protocol for a Randomized Controlled Trial. Front Psychol. 2021 Mar 9;12:630766. doi: 10.3389/fpsyg.2021.630766. eCollection 2021.
    Results Reference
    derived

    Learn more about this trial

    iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain

    We'll reach out to this number within 24 hrs